NDA 019890

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #019890

Documents

• Letter: 2002-01-14
• Label: 2002-01-14

Application Sponsors

NDA 019890

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001

Application Products

001

SPRAY, METERED;NASAL

1MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0

STADOL

BUTORPHANOL TARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1991-12-12	STANDARD
LABELING; Labeling	SUPPL	2	AP	1993-04-16	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2009-03-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	1998-03-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	1998-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-07-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	2009-03-13	STANDARD
LABELING; Labeling	SUPPL	9	AP	1998-03-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	1998-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-04-18	STANDARD
LABELING; Labeling	SUPPL	12	AP	1998-03-13	STANDARD
LABELING; Labeling	SUPPL	13	AP	1998-06-16	STANDARD
LABELING; Labeling	SUPPL	14	AP	1999-04-16	STANDARD
LABELING; Labeling	SUPPL	15	AP	2001-01-05	STANDARD
LABELING; Labeling	SUPPL	17	AP	2002-01-14	STANDARD
LABELING; Labeling	SUPPL	19	AP	2009-03-13	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19890
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"STADOL","activeIngredients":"BUTORPHANOL TARTRATE","strength":"1MG\/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/14\/2002","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19890s17lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"STADOL","submission":"BUTORPHANOL TARTRATE","actionType":"1MG\/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2002-01-14
        )

)